NCT06880406

Brief Summary

This project aims to study on one hand the early mitochondrial alterations, common or specific, occurring in peripheral cells of patients with Alzheimer's disease or related dementia and, on the other hand, identify the metabolomic biomarkers that may be at the origin of mitochondrial disturbances associated with the disease. This will be the first study combining functional analyses of mitochondria and exploratory metabolomic assessments in the same cohort at early stages of the disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
35mo left

Started Jul 2025

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Jul 2025Apr 2029

First Submitted

Initial submission to the registry

March 7, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

March 7, 2025

Last Update Submit

July 1, 2025

Conditions

Alzheimer Disease

Keywords

Alzheimermitochondrial functionmetabolomic

Outcome Measures

Primary Outcomes (2)

  • Mitochondrial oxygen consumption of peripheral blood cells

    Comparison of the rate of mitochondrial oxygen consumption of peripheral blood cells between alzheimer (amyloid positive) and non-Alzheimer participant (amyloid negative) in pmol/min/cell mesured by Extracellular Flux Analyzer

    At Baseline

  • Mitochondrial oxygen consumption of peripheral blood cells

    Comparison of the rate of mitochondrial oxygen consumption of peripheral blood cells between alzheimer (amyloid positive) and non-Alzheimer participant (amyloid negative) in pmol/min/cell mesured by Extracellular Flux Analyzer

    At 1 year

Secondary Outcomes (2)

  • Mitochondrial metabolomic signature

    At Baseline and at one year

  • Mini Mental State Examination Scores for Cognitive Impairment

    At Baseline and at one year

Study Arms (1)

ALZHEIMER PATIENTS and NON ALZHEIMER PATIENTS

EXPERIMENTAL

Recruitment of 75 patients with amyloid positive marker on cerebrospinal fluid and 75 patients with amyloid negative marker on cerebrospinal fluid

Other: MMSE and blood draw

Interventions

MMSE and blood drawOTHER

Each patient will be evaluated by Mini-Mental State Examination (MMSE) and will have a blood draw

ALZHEIMER PATIENTS and NON ALZHEIMER PATIENTS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neurocognitive disorder with spontaneous complaint or reported for at least 6 months
  • Diagnostic process according to current Haute Autorité de Santé (HAS) recommendations.
  • cerebrospinal fluid biomarker dosage done within the study center and agreement to bio-collection of residual cerebrospinal fluid
  • Patient having agreed to sign the informed consent
  • Patient affiliated or beneficiary of a social security scheme
  • For alzheimer group : diagnosis of Alzheimer's disease according to NIA-AA 2024 criteria (presence of a pathogenic amyloid process in the cerebrospinal fluid)
  • For non alzheimer group : diagnosis of mild or major neurocognitive disorder according to Manuel diagnostique et statistique des troubles mentaux edition 5 (DSM-V) criteria, not linked to Alzheimer's disease (absence of pathogenic amyloid process in the cerebrospinal fluid)

You may not qualify if:

  • \- Vulnerable people

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, PACA, 06000, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Mental Status and Dementia TestsBlood Specimen Collection

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Guillaume SACCO, MD,PhD

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Justine Lemaire

CONTACT

33492034778lemaire.j@chu-nice.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 17, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

April 1, 2029

Last Updated

July 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)